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    Summary
    EudraCT Number:2015-002160-17
    Sponsor's Protocol Code Number:Lidospray1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-04-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2015-002160-17
    A.3Full title of the trial
    UNICENTER RANDOMIZED SIMPLE BLIND CLINICAL TRIAL TO COMPARE THE EFFECTIVENESS OF LIDOCAINE SPRAY VERSUS CONVENTIONAL ANALGESIA WHILE CURES IN PATIENTS WITH COMPLEX SURGICAL WOUNDS
    ENSAYO CLÍNICO UNICÉNTRICO ALEATORIZADO CONTROLADO SIMPLE CIEGO PARA VALORAR LA EFECTIVIDAD DE LA LIDOCAÍNA EN AEROSOL FRENTE A LA ANALGESIA CONVENCIONAL EN LA CURA DE HERIDAS QUIRÚRGICAS COMPLEJAS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECTIVENESS OF LIDOCAINE SPRAY IN SURGICAL WOUNDS
    EFECTIVIDAD DE LA LIDOCAÍNA EN SPRAY EN HERIDAS QUIRÚRGICAS
    A.4.1Sponsor's protocol code numberLidospray1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDiana Molina Villaverde
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDiana Molina Villaverde
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiana Molina Villaverde
    B.5.2Functional name of contact pointDiana Molina
    B.5.3 Address:
    B.5.3.1Street Addresscalle jaén nº16 1ºctro
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28020
    B.5.3.4CountrySpain
    B.5.6E-maildianamol@ucm.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name LIDOCAINE
    D.2.1.1.2Name of the Marketing Authorisation holderFortacin
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for cutaneous spray, emulsion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlidocaina
    D.3.9.1CAS number 6108-05-0
    D.3.9.3Other descriptive nameLIDOCAINE HYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB02922MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate and solvent for solution for injection/infusion
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    analyse whether patients with intravenous analgesic treatment will have the same degree of pain that patients with the same pattern of analgesia, they make a topical application of lidocaine 2% during the wound dressing.
    Demostrar que los pacientes con tratamiento analgésico vía intravenosa van a tener el mismo grado de dolor que los pacientes que con la misma pauta de analgesia, se les realice una aplicación tópica de lidocaína al 2% durante la cura.
    E.1.1.1Medical condition in easily understood language
    analyse whether patients with analgesic treatment will have the same degree of pain that patients with the same pattern of analgesia, they make a topical application of lidocaine 2% during the cure
    Demostrar que pacientes con tratamiento analgésico van a tener el mismo grado de dolor que los pacientes con la misma analgesia y se les realice una aplicación tópica de lidocaína al 2% en la cura.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To analyse whether patients with intravenous analgesic treatment will have the same degree of pain that patients with the same pattern of analgesia, they make a topical application of lidocaine 2% during the wound dressing.
    Demostrar que los pacientes con tratamiento analgésico vía intravenosa van a tener el mismo grado de dolor que los pacientes que con la misma pauta de analgesia, se les realice una aplicación tópica de lidocaína al 2% durante la cura.
    E.2.2Secondary objectives of the trial
    Quantify pain perceived by the patient before and after performing the cure.
    To analyze the hemodynamic -related pain cure has in the two groups
    Analyze if stinging / itching while being treated with topical application of lidocaine
    Compare the absorption of lidocaine in plasma in both groups
    Analyze patient satisfaction
    1.- Cuantificar el dolor que percibe el paciente antes y después de realizar la cura.
    2.- Analizar la repercusión hemodinámica relacionada con el dolor que la cura tiene en los dos grupos
    3.- Analizar si hay sensación de escozor/picor durante la cura con la aplicación tópica de la lidocaína
    4.- Comparar la absorción de lidocaína en plasma en ambos grupos
    5.- Analizar la satisfacción del paciente
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with surgical wounds that meet criteria for complex wound (those wounds where it is better to delay the closure of the wound until the wound good granulation tissue is developed.
    Written informed consent signed
    Ability to self-assess and report their pain level .
    18 and over
    Pacientes con heridas quirúrgicas que cumplan criterios de herida compleja (aquellas heridas en las que es mejor para retrasar el cierre de la herida hasta que la herida se desarrolla buena tejido de granulación).
    Consentimiento informado escrito firmado
    Capacidad de autoevaluar e informar su nivel de dolor.
    Mayores de 18 años
    E.4Principal exclusion criteria
    Pregnancy.
    severe liver or renal dysfunction diagnosed.
    Participation in other clinical trials
    History of allergy to sulfur, lidocaine or mepivacaine, NSAIDs, or other local anesthetics and banana or derivatives
    open fractures , burns, traumatic wounds, pressure ulcers, venous ulcers, arterial ulcers , diabetic ulcers
    o El embarazo.
    o Disfunción renal o hepática grave diagnosticada.
    o Participación en otros ensayos clínicos.
    o Antecedentes de alergia a sulfuros, lidocaína o mepivacaína, antiinflamatorios no esteroideos (AINES), u otro tipo de anestésicos locales y plátano o derivados
    o Fracturas abiertas, quemaduras, heridas traumáticas, úlceras por presión, úlceras venosas, úlceras arteriales, úlceras diabéticas
    E.5 End points
    E.5.1Primary end point(s)
    Decrease the degree of pain at least one point in VAS
    practically nonexistent lidocaine plasma relationship, not related to the administration of lidocaine in wound
    Disminuir el grado del dolor al menos un punto en escala EVA
    Relación practicamente inexistente de lidocaina en plasma, no relacionada con la administración de lidocaina en herida
    E.5.1.1Timepoint(s) of evaluation of this end point
    To be considered
    E.5.2Secondary end point(s)
    Qualitatively analyze stinging / itching after administration of lidocaine in wound
    Patient satisfaction with lidocaine is at least one point above the patient without lidocaine in wound
    Analizar cualitativamente sensación de escozor/picor tras la administracion de lidocaina en herida
    Que la satisfaccion del paciente con lidocaina sea al menos un punto por encima del paciente sin lidocaina en herida
    E.5.2.1Timepoint(s) of evaluation of this end point
    To be considered
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end is defined with the last visit of the last subject undergoing the trial
    El final del trial está definido por la última visita al último paciente reclutado
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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